# K861797: Allegro Intact Parathyroid Hormone Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Jul 22, 1986 after 74 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 25, 2005 · Not classified · Z-0809-05: Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.

Source page: https://510kreport.com/device/K861797
Methodology: https://510kreport.com/methodology